JP2020525215A - Artificial heart valve device - Google Patents

Abstract

The present technology is an artificial heart valve device, as well as related systems and methods, for treating the natural valve of the human heart with natural annulus and leaflet. One embodiment comprises a valve support, an artificial valve assembly within the valve support, and a fastening member having upstream and downstream portions. The device further includes an extension member that is connected to and extends radially outward from the fixed frame. The expansion member comprises a plurality of wires, at least a portion of those wires including an inner core surrounded by an outer material. The wire contains multiple recesses that extend through at least a portion of the thickness of the outer material, and a therapeutic agent within the recesses for delivery to the anatomy when the artificial heart valve device is positioned on the natural annulus. Including. [Selection diagram] Fig. 7

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority to US patent application Ser. No. 15/642,834 filed July 6, 2017, which is hereby incorporated by reference in its entirety. is there.

This application is (1) International Patent Application No. PCT/US2014/029549 filed on March 14, 2014, (2) International Patent Application No. PCT/US2012/061219 filed on October 19, 2012. (3) International Patent Application No. PCT/US2012/061215 filed on October 19, 2012, (4) International Patent Application No. PCT/US2012/043636 filed on June 21, 2012 Incorporate the subject. This application is also filed on April 18, 2017, US Patent Application No. 15/490,047, and concurrently filed with it, US Patent Application No. 15/643,011 (Patent Attorney Docket No. C00013493.USU2) incorporated.

The present technology relates generally to prosthetic heart valve devices. Specifically, some embodiments are directed to prosthetic mitral valves and devices for percutaneous repair and/or replacement of native mitral valves, and related systems and methods.

Heart valves can be affected by several conditions. For example, the mitral valve can be affected by mitral regurgitation, mitral valve prolapse, and mitral stenosis. Mitral regurgitation is an abnormal leakage of blood from the left ventricle into the left atrium due to heart failure, where the mitral leaflets cannot join in parallel at peak systolic pressure. The mitral leaflets do not need to be well joined because heart disease often causes dilation of the myocardium, which then enlarges the natural mitral annulus to the extent that the leaflets do not join during systole. .. Abnormal reflux can also occur when the papillary muscles are functionally impaired due to ischemia or other conditions. More specifically, when the left ventricle contracts during systole, the affected papillary muscles do not contract sufficiently to achieve proper closure of the leaflets.

Mitral valve prolapse is a symptom when the mitral valve leaflets project abnormally into the left atrium. This causes irregular behavior of the mitral valve, which can lead to mitral regurgitation. The leaflets may deviate and fail to join because the tendons that connect the papillary muscles to the underside of the mitral valve leaflets (chordae tendineae) may stretch or tear. Mitral stenosis is the narrowing of the mitral valve orifice that prevents diastolic left ventricular filling.

Mitral regurgitation is often treated with diuretics and/or vasodilators to reduce the amount of blood flowing back into the left atrium. Surgical approaches (thoracotomy and endovascular) for either valve repair or replacement have also been used to treat mitral regurgitation. For example, typical repair techniques involve tightening or excising portions of the expanded annulus. Tightening includes, for example, implanting an annular or generally annular ring that is generally secured to the annulus or surrounding tissue. Other repair procedures also suture or tighten the leaflets in parallel with each other, partially in parallel.

Alternatively, a more invasive procedure replaces the entire valve by implanting a mechanical valve or biological tissue in the heart instead of the native mitral valve. These invasive procedures traditionally require extensive thoracotomy and are therefore very painful, have significant morbidity, and require a long recovery period. Moreover, in many repair and replacement procedures, device durability or improper sizing of the annuloplasty ring or replacement valve can present additional problems to the patient. Restorative procedures also require a highly skilled cardiac surgeon, as poorly or incorrectly placed sutures can affect the success of the procedure.

Recently, minimally invasive approaches to aortic valve replacement have been implemented. Examples of pre-assembled percutaneous prosthetic valves are described, for example, in Medtronic/Corevalve Inc. CoreValve Reviving® Systems from (Irvine, CA, USA), and Edwards-Sapien® Valve from Edwards Lifesciences (Irvine, CA, USA). Both valve systems include an expandable frame and a trilobal biovalve attached to the expandable frame. The aortic valve is substantially symmetrical, circular and has a muscular torus. In order to match the natural anatomy, and because the trilobal prosthesis requires circular symmetry for proper coaptation of the prosthetic leaflets, an expandable frame in aortic applications has been found in the aortic annulus. It has a symmetrical circular shape. Thus, the aortic valve anatomy is suitable for an expandable frame that houses a replacement valve, as the aortic valve anatomy is substantially uniform, symmetrical, and highly muscular. However, other heart valve anatomy is not uniform, not symmetrical, or not sufficiently muscular, so that aortic valve replacement bequest may not be appropriate for other types of heart valves.

The tricuspid valve on the right side of the heart usually has three leaflets, but like the mitral valve, it presents similar challenges for minimally invasive treatment. Therefore, there is also a need for better prostheses to treat tricuspid valve disease.

Given the difficulties associated with current procedures, there remains a need for simple and effective minimally invasive devices and methods for treating dysfunctional heart valves.

Overview Some embodiments of the present technology are directed to mitral valve replacement devices that address the unique challenges of percutaneously replacing the natural mitral valve and are suitable for delivering therapeutic agents to anatomy. And Compared to replacing the aortic valve, percutaneous mitral valve replacement faces unique anatomical obstacles that make percutaneous mitral valve replacement significantly more difficult than aortic valve replacement. First, unlike the relatively symmetric and uniform aortic valve, the mitral annulus is a non-circular D-shaped or renal, often with a non-planar saddle-like geometry that lacks symmetry. It has such a shape. The complex and highly variable anatomy of the mitral valve makes it difficult to design a mitral valve prosthesis that fits well into the natural mitral annulus of a particular patient. As a result, the prosthesis may not fit well with the native leaflets and/or annulus, which may leave gaps that allow blood regurgitation to occur. For example, placement of a cylindrical valve prosthesis within the native mitral valve may leave a gap in the commissural area of the native valve where perivalvular leakage may occur.

Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale, and instead focused on clearly illustrating the principles of the present disclosure. Furthermore, components may be shown as transparent in some figures for clarity of illustration only, not to indicate that the illustrated components are necessarily transparent. For ease of reference, the same reference numbers and/or letters are used throughout the disclosure to identify similar or similar components or features, but the use of the same reference numbers indicates that the parts are the same. Does not imply that it should be interpreted as. In fact, in many of the examples described herein, identically numbered components refer to different embodiments having separate structures and/or functions. The headings provided herein are for convenience only.

FIG. 6 is a schematic cross-sectional view of a heart showing an antegrade approach from the venous vasculature to the native mitral valve, according to various embodiments of the present technology. FIG. 6 is a schematic cross-sectional view of a heart showing access through an atrial septum (IAS) maintained by placement of a guide catheter over a guidewire, according to various embodiments of the present technology. FIG. 6 is a schematic cross-sectional view of a heart showing a retrograde approach to the native mitral valve through the aortic valve and arterial vasculature, according to various embodiments of the present technology. FIG. 6 is a schematic cross-sectional view of a heart showing a retrograde approach to the native mitral valve through the aortic valve and arterial vasculature, according to various embodiments of the present technology. FIG. 6 is a schematic cross-sectional view of a heart showing an approach to a native mitral valve using transapical puncture, according to various embodiments of the present technology. 6A is a side cross-sectional view and FIG. 6B is a top view schematically illustrating a prosthetic heart valve device, according to an embodiment of the present technology. 6A is a side cross-sectional view and FIG. 6B is a top view schematically illustrating a prosthetic heart valve device, according to an embodiment of the present technology. FIG. 6A is a top isometric view of a prosthetic heart valve device, according to an embodiment of the present technology. FIG. 7B is an enlarged view of the stranded wire of the support member of the artificial heart valve device shown in FIG. 7A. 7C is a cross-sectional view of the stranded wire shown in FIG. 7A taken along line 7C-7C. FIG. 6 is a schematic top view of a prosthetic heart valve device in a deployed configuration configured in accordance with an embodiment of the present technology. FIG. 8B is a schematic end view of the prosthetic heart valve device of FIG. 8A in a delivery configuration positioned within a delivery catheter constructed in accordance with an embodiment of the present technology. FIG. 8D is a side cross-sectional view of a portion of the prosthetic heart valve device shown in FIGS. 8A and 8B during deployment, according to embodiments of the present technology. FIG. 8D is a side cross-sectional view of a portion of the prosthetic heart valve device shown in FIGS. 8A and 8B during deployment, according to embodiments of the present technology. FIG. 8D is a side cross-sectional view of a portion of the prosthetic heart valve device shown in FIGS. 8A and 8B during deployment, according to embodiments of the present technology. FIG. 8B is an end view of three insulating segments of the expansion member of the prosthetic heart valve device of FIG. 8A shown in an overlapping and extended configuration, respectively. FIG. 8B is an end view of three insulating segments of the expansion member of the prosthetic heart valve device of FIG. 8A shown in an overlapping and extended configuration, respectively. FIG. 6A is an end view of three insulating segments of a dilating member of a prosthetic heart valve device shown in an overlapping and extended configuration, respectively. FIG. 6A is an end view of three insulating segments of a dilating member of a prosthetic heart valve device shown in an overlapping and extended configuration, respectively. FIG. 6A is an end view of three insulating segments of a dilating member of a prosthetic heart valve device shown in an overlapping and extended configuration, respectively. FIG. 6A is an end view of three insulating segments of a dilating member of a prosthetic heart valve device shown in an overlapping and extended configuration, respectively. 8 is a schematic isometric view of a prosthetic heart valve device according to another embodiment of the present technology. FIG.

Specific details of some embodiments of the present technology are described below with reference to FIGS. Many of the embodiments are described below with respect to prosthetic valve devices, systems, and methods for percutaneous replacement of a native mitral valve, although in addition to those described herein, other applications and Other embodiments are within the scope of the present technology. In addition, some other embodiments of the present technology may have different configurations, components, or procedures than those described herein. Thus, one of ordinary skill in the art may have other embodiments where the technology is with additional elements, or the technology is shown and described below with reference to FIGS. It will be appreciated that other embodiments may be provided without some of the.

With respect to the terms "distal" and "proximal" within this description, unless otherwise specified, the term refers to a location within the operator and/or vasculature or heart to the prosthetic valve device and/or associated delivery. It can refer to the relative position of parts of the device. For example, when referring to a delivery catheter suitable for delivering and positioning the various prosthetic valve devices described herein, “proximal” means a position closer to the incision of the device into the operator or vasculature. Can be referred to as “distal” and can refer to a location that is more distal from the device operator or further away from the incision along the vasculature (eg, the end of the catheter). With respect to prosthetic heart valve devices, the terms "proximal" and "distal" can refer to the location of portions of the device with respect to the direction of blood flow. For example, proximal can refer to an upstream location, or a location where blood flows into the device (eg, inflow area), and distal can refer to a downstream location, or where blood exits the device (eg, outflow area). ) Can be pointed out.

Current prosthetic valves developed for percutaneous aortic valve replacement are unsuitable for use in mitral valves. First, many of these devices require a direct structural connection between the stent-like structure that contacts the annulus and/or leaflets and the prosthetic valve. In some devices, the stent posts that support the prosthetic valve also contact the annulus or other surrounding tissue. These types of devices directly transfer the force exerted by the tissue and blood as the heart contracts to the valve support and prosthetic leaflets, which in turn, from its desired cylindrical shape. Distort the body. This is because most heart replacement devices require a substantially symmetrical cylindrical support around the prosthetic valve for proper opening and closing of the three leaflets over the years of life, It is a concern because it uses a tri-leaflet valve. As a result, when these devices are subject to motion and forces from the annulus and other surrounding tissue, the prosthesis can be compressed and/or distorted, rendering the artificial valve leaflets dysfunctional. Also, the diseased mitral valve annulus is much larger than any available prosthetic aortic valve. As the size of the valve increases dramatically, the force on the leaflets increases dramatically, so simply increasing the size of the artificial aorta to the size of the dilated mitral annulus is dramatically thicker and longer. It requires cusps and will not be feasible.

In addition to its irregular and complex shape, which changes size during each beat, the mitral annulus lacks a significant amount of radial support from surrounding tissue. Compared to the aortic valve, which is completely surrounded by fibroelastic tissue, which provides sufficient support to anchor the prosthetic valve, the mitral valve is bound only by muscle tissue on the outer wall. The inner walls of the mitral valve anatomy are joined by a thin vessel wall that separates the mitral annulus from the lower portion of the aortic outflow tract. As a result, significant radial forces on the mitral valve annulus, such as those exerted by expanding the stent prosthesis, can lead to collapse of the lower portion of the aortic tract. Moreover, larger prostheses exert more force and expand to larger dimensions, thereby exacerbating this problem for mitral valve replacement applications.

The chordae chordae of the left ventricle may also present an obstacle in deploying a prosthetic mitral valve. Unlike the aortic valve, the mitral valve has a labyrinthine chordae below the leaflets in the left ventricle that limit the movement and position of the deployment catheter and exchange device during implantation. As a result, deploying, positioning and anchoring the valve replacement device on the ventricular side of the native mitral valve annulus is complicated.

Embodiments of the present technology address the challenges associated with mitral valve anatomy and provide for the delivery of therapeutic agents to local anatomy to treat a body heart valve, such as the mitral valve. Systems, methods, and devices. The present devices and methods allow a percutaneous approach using a catheter that is delivered intravascularly through a vein or artery into the heart or through a cannula inserted through the heart wall. For example, the devices and methods are particularly suitable for transseptal approaches, but may be transapical, transatrial, and direct aortic delivery of artificial replacement valves to target locations within the heart. In addition, embodiments of devices and methods as described herein are known for accessing cardiac valves (eg, mitral or tricuspid valves) with antegrade or retrograde approaches and combinations thereof. Can be combined with many known surgeries and procedures, such as

Access to the Mitral Valve To better understand the structure and operation of valve replacement devices according to the present technology, it is helpful to first understand the approach for implanting the device. The mitral valve or other type of atrioventricular valve can be accessed through the patient's vasculature in a percutaneous manner. Percutaneous is typically accessed through the skin at a location in the vasculature that is remote from the heart, using, for example, surgical incision procedures or minimally invasive procedures, such as the use of needle access through the Seldinger technique. Means to be done. The ability to percutaneously access remote vascular systems is well known and described in the patent and medical literature. Depending on the point of vascular access, access to the mitral valve may be antegrade and may depend on entry into the left atrium by crossing the atrial septum (eg, transseptal approach). .. Alternatively, access to the mitral valve may be retrograde, entering the left ventricle through the aortic valve. Access to the mitral valve may be achieved using a cannula via a transapical approach. Depending on the approach, the interventional tool and supporting catheter(s) may be advanced endovascularly to the heart and positioned adjacent the target heart valve in a variety of manners as described herein. Good.

FIG. 1 shows the stages of a transseptal approach for implanting a valve replacement device. In the transseptal approach, through the inferior vena cava IVC or superior vena cava SVC, through the right atrium RA, across the atrial septum IAS, and into the left atrium LA above the mitral valve MV. .. As shown in FIG. 1, a catheter 1 with a needle 2 is moved from the inferior vena cava IVC into the right atrium RA. Once the catheter 1 reaches the anterior side of the atrial septum IAS, the needle 2 is advanced through the septum, for example at the fossa ovalis or foramen ovale into the left atrium LA. At this point the guide wire is replaced with the needle 2 and the catheter 1 is withdrawn.

FIG. 2 shows the latter stage of the transseptal approach, where the guidewire 6 and guide catheter 4 pass through the atrial septum IAS. The guide catheter 4 provides access to the mitral valve for implanting a valve replacement device according to the present technology.

An alternative antegrade approach (not shown) may provide surgical access through an intercostal incision, preferably without removing the ribs, even if a small perforation or incision is made in the left atrial wall. Good. The guide catheter is then passed through this perforation or incision directly into the left atrium and sealed with a purse string suture.

An antegrade or transseptal approach to the mitral valve as described above can be advantageous in many ways. For example, the antegrade approach will typically allow more accurate and effective centering and stabilization of the guide catheter and/or prosthetic valve device. The antegrade approach may also reduce the risk of damaging chordae chordae or other subvalvular structures with catheters and other interventional tools. In addition, the antegrade approach may reduce the risk associated with traversing the aortic valve as in the retrograde approach. This may be particularly relevant for patients with prosthetic aortic valves that cannot be traversed without any or substantial risk of injury.

3 and 4 show an example of a retrograde approach to access the mitral valve. Access to the mitral valve MV may be achieved from the aortic arch AA, across the aortic valve AV, and into the left ventricle LV below the mitral valve MV. The aortic arch AA may be accessed through the conventional femoral artery access route or through a more direct approach through the brachial, axillary, radial, or carotid arteries. Such access may be achieved through the use of guidewire 6. Once in place, the guide catheter 4 may be tracked over the guide wire 6. Alternatively, a surgical approach may be taken, preferably by placing a guide catheter through the perforation of the aorta itself, intercostally without removing the ribs, and through an incision in the chest. The guide catheter 4 provides subsequent access to allow placement of the prosthetic valve device, as described in further detail herein. The retrograde approach advantageously does not require transseptal perforation. Cardiologists also more commonly use the retrograde approach, and therefore the retrograde approach is well known.

FIG. 5 shows a transapical approach via transapical perforation. In this approach, access to the heart is through a thoracotomy, which may be a conventional thoracotomy or sternotomy, or a smaller intercostal or subxiphoid incision or perforation. An access cannula is then placed through the perforation in the wall of the left ventricle at or near the apex of the heart. The catheter and prosthesis of the present invention may then be introduced into the left ventricle through this access cannula. The transapical approach provides a shorter, straighter straight path to the mitral or aortic valve. Furthermore, because it does not involve intravascular access, the transapical approach does not require interventional cardiology training to perform the catheterization required by other percutaneous approaches.

Selected Embodiments of Prosthetic Heart Valve Devices and Methods Embodiments of the present technology may treat one or more of the valves of the heart, and in particular, some embodiments may advantageously be a mitral valve. To treat. The prosthetic valve device of the present technology may also be suitable for replacement of other valves (eg, bicuspid or tricuspid valves) in the patient's heart. Examples of prosthetic heart valve devices according to embodiments of the present technology are described in this section with reference to FIGS. 6A-10. Certain elements, substructures, advantages, applications, and/or other features of the embodiments described with reference to FIGS. 6A-10 may be suitably interchanged, substituted, or otherwise configured with each other. Moreover, suitable elements of the embodiments described with reference to Figures 6A-10 can be used as stand-alone and/or self-contained devices.

6A is a side cross-sectional view and FIG. 6B is a plan view of a prosthetic heart valve device (“device”) 100 according to an embodiment of the present technology. The device 100 includes a valve support 110, an anchoring member 120 attached to the valve support 110, and a prosthetic valve assembly 150 within the valve support 110. Referring to FIG. 6A, the valve support 110 has an inflow region 112 and an outflow region 114. The prosthetic valve assembly 150 is arranged in the valve support 110 to allow blood to flow from the inflow region 112 to the outflow region 114 (arrow BF), while allowing blood to flow from the outflow region 114 to the inflow region 112. Prevent flow in the direction.

In the embodiment shown in FIG. 6A, the anchoring member 120 includes a base 122 attached to the outflow region 114 of the valve support 110 and a plurality of arms 124 that project laterally outwardly from the base 122. .. The fixation member 120 also includes a fixation structure 130 extending from the arm 124. The fixation structure 130 can include a first portion 132 and a second portion 134. The first portion 132 of the anchoring structure 130 can be, for example, an upstream region of the anchoring structure 130, the anchoring structure 130 having a gap G in the inlet region 112 of the valve support 110 in the deployed configuration as shown in FIG. 6A. Laterally spaced outwards from. The second portion 134 of the anchoring structure 130 may be the most downstream portion of the anchoring structure 130. The fixation structure 130 can be a cylindrical ring (eg, a straight cylinder, or a conical shape), the outer surface of the fixation structure 130 having an annular engagement surface configured to press outward against the native valve annulus. Can be defined. The fixation structure 130 may further include a plurality of fixation elements 136 that project radially outward and slope toward the upstream direction. The fixation element 136 can be, for example, a hook, hook, or other element that is inclined only in the upstream direction (eg, the direction extending away from the downstream portion of the device 100).

Still referring to FIG. 6A, the anchoring member 120 has a smooth bend 140 between the arm 124 and the anchoring structure 130. For example, the second portion 134 of the anchoring structure 130 extends from the arm 124 with a smooth bend 140. The arms 124 and the anchoring structure 130 may be integrally formed from continuous struts or support elements such that the smooth bend 140 is a bent portion of the continuous struts. In other embodiments, the smooth bend 140 can be a separate component for either the arm 124 or the anchoring structure 130. For example, the smooth bend 140 may be attached to the arm 124 and/or the anchoring structure 130 using welding, adhesives, or other techniques that form a smooth connection. The smooth bend 140 is configured such that the device 100 can be recaptured within a capsule or other container after the device 100 has been at least partially deployed.

The device 100 can further include a first sealing member 162 on the valve support 110 and a second sealing member 164 on the anchoring member 120. The first sealing member 162 and the second sealing member 164 can be made from a flexible material such as Dacron® or another type of polymeric material. The first sealing member 162 can cover the inner surface and/or the outer surface of the valve support 110. In the embodiment shown in FIG. 6A, the first sealing member 162 is attached to the inner surface of the valve support 110 and the prosthetic valve assembly 150 includes the first sealing member 162 and the commissure of the valve support 110. Attached to the part. The second sealing member 164 is attached to the inner surface of the fixing member 120. As a result, the outer annular engaging surface of the anchoring structure 130 is not covered by the second sealing member 164 such that the outer annular engaging surface of the anchoring structure 130 directly contacts the tissue of the native valve annulus.

The device 100 can further include an expansion member 170. The expansion member 170 can be an expansion portion of the second sealing member 164, or it can be a separate component attached to the second sealing member 164 and/or the first portion 132 of the fixation structure 130. Can be The expansion member 170 can be a flexible member that flexes with respect to the first portion 132 of the fixation structure 130 in the deployed state shown in FIG. 6A. During operation, the expansion member 170 slides the device 100 during implantation so that the device is at the desired elevation and centered against the native annulus. As described below, the expansion member 170 can include a support member, such as a metal wire or other structure, that can be visualized and/or configured to deliver a therapeutic agent during implantation.

FIG. 7A is a top isometric view of an example of device 100. In this embodiment, the valve support 110 defines a first frame (eg, an inner frame) and the anchoring structure 130 of the anchoring member 120 includes a second frame (eg, an outer frame) each including a plurality of structural elements. Frame). The anchoring structure 130 is more specifically arranged within a diamond-shaped cell 138 that together form an at least substantially cylindrical ring when expanded fully and freely as shown in FIG. 7A. Structure element 137. Structural element 137 may be a strut or other structural feature formed of metal, polymer, or other suitable material that is self-expandable or expandable by a balloon or other type of mechanical expander.

Some embodiments of the locking structure 130 can be a generally cylindrical locking ring having an outwardly engaging surface. For example, in the embodiment shown in FIG. 7A, the outer surface of structural element 137 defines an annular engagement surface that is configured to urge outward against the deployed native valve annulus. In the fully expanded state without any restrictions, the fixation structure 130 is substantially at least parallel to the valve support 110. However, the anchoring structure 130 can bend inward (arrow I) in the deployed state when it is pressed radially outwardly against the inner surface of the native annulus of the heart valve.

The embodiment of the device 100 shown in FIG. 7A includes a first sealing member 162 aligned along the inner surface of the valve support 110 and a second sealing member 164 along the inner surface of the anchoring structure 130. including. The expansion member 170 includes a support member 174 that includes a flexible web 172 (eg, fabric) and a plurality of strands 180 (eg, wires, struts, cables, ribbons, fibers, etc.) attached to the flexible web 172. And. The flexible web 172 can extend from the second sealing member 164 without a metal-to-metal connection between the stationary structure 130 and the support member 174. For example, the expansion member 170 can be an extension of the material of the second sealing member 164. Some embodiments of the expansion member 170 are thereby soft structures that can be easily flexed with respect to the anchoring structure 130.

7B is an enlarged view of a portion of one of the strands 180 of the support member 174 shown in FIG. 7A, and FIG. 7C is a strand 180 shown in FIG. 7B taken along line 7C-7C. FIG. 7B and 7C together, at least a portion of the stranded wire 180 can include an inner core 186 surrounded by an outer material 184 having a thickness t. The outer material 184 can be a first material and the inner core 186 can be a second material that is different than the first material. For example, in some embodiments, at least a portion of the stranded wire 180 is a drawn wire formed from at least two dissimilar materials such that the stranded wire 180 includes the desired physical and mechanical properties of each of the dissimilar materials. Filling tube ("DFT's"). In the embodiment shown in FIGS. 7A-7C, the outer material 184 is a superelastic alloy (eg, Nitinol, Cobalt Chromium, MP35N®, etc.) that provides structural support for the stranded wire 180, and the inner core 186. Is a radiopaque material (eg, platinum, tantalum, tungsten, palladium, gold, silver, etc.) that improves the visualization of the support member 174 and/or provides additional structural support for the stranded wire 180. is there.

In certain embodiments, the stranded wire 180 further comprises an optional intermediate material 185 (FIG. 7C, shown in dashed lines) positioned between the outer material 184 and the inner core 186. In such an embodiment, the inner core material and the outer material 184 may be the same and the intermediate material 185 may be a different material. For example, the outer material 184 and inner core material may be the first material and the intermediate material 185. It may be a second material different from the first material. For example, the outer material 184 and the inner core material 186 may be a superelastic alloy (eg, Nitinol, cobalt-chrome, etc.), and the intermediate material 185 may be a radiopaque material (eg, platinum, tantalum, palladium, etc.). Gold). In other embodiments, outer material 184, inner core material, and intermediate material 185 are different materials. In yet other embodiments, the stranded wire 180 may include more than three layers of material.

As shown in FIGS. 7B and 7C, at least a portion of the stranded wire 180 includes a plurality of recesses 182 extending through at least a portion of the thickness t of the outer material 184 and one or more therapeutic agents 188 within the recess 182. ,including. In some embodiments, one or more of the recesses 182 may have a depth that extends through the overall thickness t of the outer material 184 such that the top surface of the inner core 186 is exposed through the recesses 182. .. In certain embodiments, one or more of the recesses 182 extend through the entire thickness of the outer material 184 and a portion of the thickness of the inner core 186 such that the recesses 182 terminate at a depth within the inner core 186. You may. In any of the foregoing embodiments, the therapeutic agent 188 may be located on the inner core 186 or the inner core 186 may be impregnated with the therapeutic agent 188. In other embodiments, the recess 182 extends only through a portion of the thickness t of the outer material 184 such that the inner core 186 is not exposed and the recess 182 terminates at an intermediate depth within the outer material 184. In such embodiments, therapeutic agent 188 may be positioned on the exposed interior surface of outer material 184. Additionally, the stranded wire 180 may include recesses that extend to different depths within the outer material 184 and/or the inner core 186. Moreover, in those embodiments that include an intermediate material 185, the stranded wire 180 extends through the outer layer and through one or more first recesses that expose the intermediate material 185 and through the outer material 184 and the intermediate material 185. One or more second recesses that extend and expose the inner core 186. In some embodiments, the recess 182 is a through hole that passes through the complete cross-sectional dimension (eg, diameter) of the stranded wire 180. In any of the foregoing embodiments, the therapeutic agent 188 may occupy all or a portion of the recess 182.

Although the recesses 182 shown in FIGS. 7A-7C have a circular cross-sectional shape, in other embodiments, one or more of the recesses have other suitable cross-sectional shapes (eg, square, oval, rectangular, etc.). You may have. Similarly, one or more of the recesses 182 can have the same or different cross-sectional areas (at recesses at different depths). For example, one or more of the recesses 182 may have a decreasing cross-sectional area towards the bottom surface of the recess. Also, at least some of the recesses 182 may be located at the same peripheral position along the strand and/or at least some of the recesses 182 may have different peripheral positions. .. Moreover, in some embodiments, the plurality of recesses may be located at the same axial position along the strand 180. In other embodiments, all of the recesses 182 are located at different axial positions along the strand.

A suitable therapeutic agent 188 reduces the inflammation in the valve annulus and promotes ingrowth between the expansion member 170 and one or more of the leaflets and/or the atrial bed and one or more drugs and And/or may include a bioactive agent. Thus, the incorporation of one or more therapeutic agents 188 can increase the resistance and incorporation of a prosthetic heart valve device and/or reduce paravalvular leakage. Examples of suitable anti-inflammatory agents include paclitaxel, sirolimus and the like. Examples of bioactive agents include platelet-derived growth factor (“PDGF”), fibroblast growth factor (“FGF”), mutant growth factor (“TGF”), and endothelial cells, smooth muscle cells, and fibroblasts. And one or more growth factors, such as other suitable mitogens that stimulate the growth of E. coli.

In some embodiments, therapeutic agent 188 may be configured to have a controlled delivery rate over a desired time period. For example, therapeutic agent 188 may also be associated with (eg, encapsulated by, and attached to, a delivery vehicle) a delivery vehicle (eg, a bioresorbable polymer blend, etc. for sustained release of therapeutic agent 188). Good. In certain embodiments, the web may be impregnated with the bioactive agent or bioactive agent and delivery vehicle to control the rate of release of the bioactive agent.

The embodiment illustrated in FIG. 7A illustrates a generally coaxial arrangement of strands 180 forming a serpentine pattern of crosses (eg, zigzag pattern, diamond pattern), while one or more strands 180 other. Arrays and patterns (eg, serpentine, wavy, radial arms, squares, etc.) can also be formed to provide the desired rigidity to the expansion member 170. Moreover, although the support member 174 shown in FIG. 7A is separate from the fixation structure 130, in other embodiments the support member 174 is integral with the fixation structure 130. Additionally, support member 174, valve support 110, and/or anchoring member 120 may include a mixture of materials, alloys, struts, wires, strand types, and/or strand dimensions, as described above. Good. For example, in some embodiments, a portion of the structure, struts, or strands may be of DFT, and another portion of the structure, struts, or strands may be made of polymer fibers and/or metal wires. Good. In certain embodiments, the expansion member comprises an annular woven web and a braided superelastic material (eg, Nitinol) within the hem of the fabric or as strips perpendicular to the circumference of the annular web. In any of the embodiments disclosed herein, the expansion member may include a platinum impregnated fabric and/or a thin film superelastic material (eg, Nitinol) deposited on the fabric. In addition, any of the structural members disclosed herein may include one or more laser-cut Nitinol strips (eg, straight strips, curved strips, etc.). In some embodiments, one or more portions of structural member, support member 174, valve support 110, and/or anchoring member 120 have been riveted with a radiopaque marker. It may have one or more holes.

8A is a schematic top view of another embodiment of a prosthetic heart valve device 200 (“device 200”) in a deployed configuration, and FIG. 8B shows the device 200 in a delivery configuration positioned within the delivery catheter C lumen. It is a schematic end view. 8C-8E are taken along line 8C-8E (FIG. 8B) when device 200 is deployed (delivery catheter C not shown in FIGS. 8C-8E for ease of illustration). 3 is a cross-sectional view of device 200. FIG. Device 200 may include several components that are generally similar in structure and function to device 100 in FIGS. 6A-7C. For example, device 200 is not visible in valve support 110 (FIG. 8A), anchoring member 120 (FIG. 8A), prosthetic valve assembly 150 (FIG. 8A), and second sealing member 164 (FIGS. 8A-8E). ), all of which are generally similar to those described above with reference to Figures 6A-7C. Thus, common motions and structures and/or substructures are identified by the same reference number, and only significant differences in motions and structures are described below.

Referring to FIG. 8A, device 200 includes an expansion member 270 having a plurality of individual fabric segments 290 around it (only one segment 290 is labeled in FIG. 8 for ease of illustration), each The individual fabric segment 290 has a first end 295 on the fastening member 120, a second end 297 spaced from the fastening member 120, and a width extending between the opposing edges 291. .. In some embodiments, adjacent segments 290 have flexible portions 292 (see FIGS. 9A and 9B) attached to their respective edges 291 such that the edges 291 slide freely relative to each other. It may be connected along.

9A and 9B are end views of three adjacent insulating segments (referred to as "first to third segments 290a-c", respectively) shown in overlapping and extended configurations, respectively. In the overlapping configuration (FIG. 9A), the edge 291a of the first segment 290a and the edge 291c of the third segment 290c overlap the adjacent edge 291b of the second segment 290b. In response to one or more forces exerted on the expansion member 270 by the surrounding anatomy, portions of the first to third segments 290a-c are spaced apart from one another in a circumferentially opposite direction (FIG. 9A). At (indicated by arrow A1), which causes edges 291a and 291c to slide in the circumferential direction C relative to edge 291b. Depending on the force exerted, edges 291a and 291c may slide over corresponding adjacent edges 291b, which causes first to third segments 290a-c to move to edge 291a. And 291c are in an extended configuration (FIG. 9B) along the perimeter C of the expansion member 270 and spaced from corresponding adjacent edges 291b. In some embodiments, each of the edges 291a and 291c may be separated from the corresponding adjacent edge 291b by no more than the length of the flexible portion 292. Of the first to third segments 290a-c when the first to third segments 290a-c are in an extended configuration and one or more forces are exerted on the expansion member 270 by the surrounding anatomy. At least some of them may move circumferentially in opposite directions (indicated by arrow A2 in FIG. 9B).

In some embodiments, expansion member 270 and/or segment 290 can have other configurations. For example, FIGS. 9C and 9D show three insulating segments 290a-290c (collectively "segment 290") of an expansion member 270' configured according to another embodiment of the present technology, shown in overlapping and extended configurations, respectively. FIG. Similarly, FIGS. 9E and 9F show three insulating segments 290a-290c (collectively “segment 290”) of another expansion member 270″ constructed according to the present technique, shown in overlapping and extended configurations, respectively. It is an end view. In some embodiments, as shown in FIGS. 9C-9F, the segments 290 are not connected by their flexible portions 292 along their respective edges 291. When the device 200 is positioned within the annulus, the plurality of segments 290 move relative to each other to conform to the natural geometry of the annulus and/or adjust their relative position as needed. While expandable member 270 may seal with local cardiac anatomy.

In some embodiments, individual segments 290 extend along and/or define at least a portion of their respective edges, and/or support members 274 (eg, metal or polymer strands). ), the flexible web 272 (eg, fabric) may extend between the support members 274 of each segment 290. In such an embodiment, flexible portion 292 may comprise a separate flexible web extending between edges 291 of adjacent segments 290. In other embodiments, the expansion members 270 and/or individual segments 290 may have other suitable configurations. For example, in some embodiments, the individual segments 290 include support members 274 (eg, metal or polymer strands) that extend radially outwardly from the anchoring structure 130, and each individual segment 290 includes a respective It has at least one support member covered by a flexible web 272 (eg, fabric) extending from the support member 274. In some embodiments, at least a portion of the flexible web 272 of each individual segment 290 overlaps at least a portion of the flexible web 272 of an adjacent individual segment member 290. In some embodiments, flexible web 272 extends between support members 274 of each segment 290. In some embodiments, the expansion member 270 comprises a flexible web 272 that is continuous around the anchoring structure 130. For example, in one embodiment, the flexible web 272 may comprise one or more pockets that allow individual support members 290 to freely move or slide within the one or more pockets. In one embodiment, the number of flexible web pockets is equal to the number of individual support members. In an alternative embodiment, the number of pockets is less than the number of individual support members. For example, in one embodiment, all of the individual support members are in a single pocket.

FIG. 10 is a schematic isometric view of a prosthetic heart valve device 300 according to another embodiment of the present technology. Device 300 may include a number of components that are generally similar in structure and function to device 100 in FIGS. 6A-7C. For example, the device 300 can include a valve support 110, an anchoring member 120, a prosthetic valve assembly 150, and a second sealing member 164, all of which are described above with reference to Figures 6A-7C. It is almost similar to the one. Thus, common motions and structures and/or substructures are identified by the same reference number, and only significant differences in motions and structures are described below.

In the embodiment shown in FIG. 10, the expansion member 370 includes a first annular portion 370a extending radially outward from the anchoring member 120 and a first annular portion 370a extending radially outward from the first annular portion 370a. And two annular portions 370b. The first annular portion 370a includes a plurality of individual segments 390a and flexible portions 392 (only one of each), similar to the segment 290 and flexible portion 292 of the expansion member 270 shown in FIGS. 8-9B. Labeled). The second annular portion 370b also includes a plurality of individual segments 390b and flexible portions 392b (one of each), similar to the segment 290 and flexible portion 292 of the expansion member 270 shown in FIGS. 8-9B. Labeled only). As shown in FIG. 10, in some embodiments, the segment 390b of the second annular portion 370b is circumferentially aligned with the segment 390b of the first annular portion 370a and of the second annular portion 370b. The flexible portion 392b is circumferentially aligned with the flexible portion 392a of the first annular portion 370a.

The following examples illustrate some embodiments of the present technology.
1. An artificial heart valve device,
A fixing member having an annular fixing frame having an upstream portion and a downstream portion,
A tubular valve support having a first portion connected to the downstream portion of the stationary frame and a second portion radially inwardly spaced from the upstream portion of the stationary frame;
At least movable from a closed position connected to the valve support and blocking blood flow through the valve support, and an open position allowing blood flow through the valve support in the downstream direction. A valve assembly having one leaflet;
An expansion member coupled to the stationary frame and extending radially outwardly therefrom, the expansion member including a plurality of wires, at least a portion of the wires being surrounded by an outer material. (A) the inner core is a first material, (b) the outer material is a second material different from the first material, and has a thickness; ) The wire includes a plurality of recesses extending through at least a portion of the thickness of the outer material; A prosthetic heart valve device within the recess for delivery to the prosthetic heart valve device.
2. The device of example 1 wherein the upstream portion of the stationary frame is radially deformable without substantially deforming the second portion of the tubular valve support.
3. The device of example 1 or example 2, wherein the expansion member further comprises a sealing member extending along at least a portion of its length, and the wire is coupled to the sealing member.
4. The device of any one of Examples 1-3, wherein the wire is integral with the upstream portion of the stationary frame.
5. The device of any one of Examples 1-3, wherein the wire is mechanically isolated from the fixed frame.
6. The device of any one of Examples 1-5, wherein the first material is radiopaque and the second material is a superelastic alloy.
7. The device of any one of Examples 1-6, wherein the therapeutic agent comprises at least one of an anti-inflammatory agent and a bioactive agent.
8. The device of any one of Examples 1-7, wherein at least some of the plurality of recesses extend through the entire thickness of the outer material, thereby exposing at least a portion of the inner core. ..
9. At least some of the plurality of recesses extend through the overall thickness of the outer material and at least a portion of the thickness of the inner core, such that at least some of the plurality of recesses include: The device of any one of Examples 1-8, terminating at an intermediate depth within the inner core.
10. 10. The device of any one of Examples 1-9, wherein the expansion member further comprises an intermediate material positioned between the inner core and the outer material.
11. The device of example 10, wherein at least some of the recesses extend through the entire thickness of the outer material, thereby exposing at least a portion of the intermediate material.
12. The device of Example 10, wherein at least some of the recesses extend through the entire thickness of the outer material and the intermediate material, thereby exposing at least a portion of the inner core. ..
13. An artificial heart valve device,
A fixing member having an annular fixing frame having an upstream portion and a downstream portion,
A tubular valve support having a first portion connected to the downstream portion of the anchoring member and a second portion radially inwardly spaced from the upstream portion of the anchoring member;
At least movable from a closed position connected to the valve support and blocking blood flow through the valve support, and an open position allowing blood flow through the valve support in the downstream direction. A valve assembly having one leaflet;
An expansion member coupled to the stationary frame and extending radially outwardly therefrom, the expansion member comprising a plurality of wires, at least a portion of the wires defining an inner core surrounded by an outer material. Including (a) the inner core is a first material, (b) the outer material is a second material different from the first material, and has a thickness; (c) The wire includes a plurality of recesses extending through at least a portion of the thickness of the outer material, and (d) a radiopaque material in the recesses; and an expansion member. device.
14. 14. The device of example 13, wherein the upstream portion of the stationary frame is radially deformable without substantially deforming the second portion of the tubular valve support.
15. 15. The device of example 13 or example 14, wherein the expansion member further comprises a sealing member extending along at least a portion of its length and the wire is coupled to the sealing member.
16. 16. The device of any one of Examples 13-15, wherein the wire is integral with the upstream portion of the stationary frame.
17. 16. The device according to any one of Examples 13-15, wherein the wire is mechanically insulated from the fixed frame.
18. 18. The device according to any one of Examples 13-17, wherein the first material is radiopaque and the second material is a superelastic alloy.
19. The device of any one of Examples 13-18, wherein the therapeutic agent comprises at least one of an anti-inflammatory agent and a bioactive agent.
20. The device of any one of Examples 13-19, wherein at least some of the plurality of recesses extend through the entire thickness of the outer material, thereby exposing at least a portion of the inner core. ..
21. At least some of the plurality of recesses extend through the overall thickness of the outer material and at least a portion of the thickness of the inner core, such that at least some of the plurality of recesses include: 21. The device according to any one of Examples 13-20, terminating at an intermediate depth within the inner core.
22. 22. The device of any one of Examples 13-21, wherein the expansion member further comprises an intermediate material positioned between the inner core and the outer material.
23. 23. The device of example 22, wherein at least some of the recesses extend through the entire thickness of the outer material, thereby exposing at least a portion of the intermediate material.
24. 23. The device of example 22, wherein at least some of the recesses extend through the total thickness of the outer material and the intermediate material, thereby exposing at least a portion of the inner core. ..
27. An artificial heart valve device,
An anchoring member having a radially expandable frame with an interior and an upstream portion and a downstream portion, the upstream portion being located at and/or downstream of a natural annulus of a heart valve of interest. An anchoring member comprising a tissue anchoring portion configured to be pressed outwardly against tissue and configured to be at least partially deformable to conform to the shape of said tissue;
A closed position that is positioned with respect to the fixing member and that blocks blood flow through the interior, and an open position that allows blood flow through the interior in the direction of flow from the upstream portion to the downstream portion A valve having at least one leaflet movable from the valve, the valve remaining capable when the tissue anchoring portion is deformed to conform to the shape of the tissue. A valve inwardly spaced from the tissue fixation portion of the fixation member;
A expansion assembly extending laterally away from the upstream portion of the securing member in a deployed configuration, the expansion member being spaced apart from the first end of the securing member and the securing member. A plurality of individual fabric sections having an end of, the fabric sections being arranged side by side around the expansion member, and adjacent fabric sections being loosely coupled together by a flexible coupling means. A dilation assembly whereby the second ends of adjacent textile sections may be configured independently of each other in the deployed state.
28. The prosthetic heart valve device of Example 27, wherein the segment does not include a structural member.
29. 29. The prosthetic heart valve device of example 27 or example 28, wherein the expansion member is configured to deform with respect to the expandable frame in the deployed configuration.
30. The prosthetic heart valve device of any one of Examples 27-29, wherein the connecting means is elastic.
31. The artificial heart valve device according to any one of Examples 27 to 29, wherein the connecting means is a suture.
32. The prosthetic heart valve device of any one of Examples 27-31, wherein the distal end of the segment coincides with the second end of the expansion member.
33. 33. The prosthetic heart valve device of any one of Examples 27-32, wherein the segment is spaced from the expandable frame such that the segment is only indirectly connected to the anchoring member.
34. The prosthetic heart valve device of any one of Examples 27-32, wherein the segment is directly connected to the expandable frame.

While the above describes specific embodiments of the present invention for purposes of illustration, it is understood that various modifications may be made without departing from the scope of the present invention. Will. For example, some individual components may be interchangeable with each other in different embodiments. Therefore, the present invention is not limited except as by the appended claims.

Claims (34)

An artificial heart valve device,
A fixing member having an annular fixing frame having an upstream portion and a downstream portion,
A tubular valve support having a first portion connected to the downstream portion of the stationary frame and a second portion radially inwardly spaced from the upstream portion of the stationary frame;
At least movable from a closed position connected to the valve support and blocking blood flow through the valve support, and an open position allowing blood flow through the valve support in the downstream direction. A valve assembly having one leaflet;
An expander member coupled to the stationary frame and extending radially outwardly therefrom, the expander member comprising a plurality of wires, at least a portion of the wires being surrounded by an outer material. (A) the inner core is a first material, (b) the outer material is a second material different from the first material, and has a thickness; ) The wire includes a plurality of recesses extending through at least a portion of the thickness of the outer material, and (d) for delivery to an anatomy when the prosthetic heart valve device is positioned in a native annulus. A prosthetic heart valve device comprising: a therapeutic agent in the recess of the. The device of claim 1, wherein the upstream portion of the stationary frame is radially deformable without substantially deforming the second portion of the tubular valve support. The device of claim 1, wherein the expansion member further comprises a sealing member extending along at least a portion of its length, the wire being coupled to the sealing member. The device of claim 1, wherein the wire is integral with the upstream portion of the stationary frame. The device of claim 1, wherein the wire is mechanically isolated from the fixed frame. The device of claim 1, wherein the first material is radiopaque and the second material is a superelastic alloy. The device of claim 1, wherein the therapeutic agent comprises at least one of an anti-inflammatory agent and a bioactive agent. The first material is radiopaque,
The second material is a superelastic alloy,
The device of claim 1, wherein the therapeutic agent comprises at least one of an anti-inflammatory agent and a bioactive agent. The device of claim 1, wherein at least some of the plurality of recesses extend through the entire thickness of the outer material, thereby exposing at least a portion of the inner core. At least some of the plurality of recesses extend through the overall thickness of the outer material and at least a portion of the thickness of the inner core, such that at least some of the plurality of recesses include: The device of claim 1, terminating at an intermediate depth within the inner core. The device of claim 1, wherein the expansion member further comprises an intermediate material positioned between the inner core and the outer material. 12. The device of claim 11, wherein at least some of the recesses extend through the entire thickness of the outer material, thereby exposing at least a portion of the intermediate material. 12. The device of claim 11, wherein at least some of the recesses extend through the entire thickness of the outer material and the entire thickness of the intermediate material, thereby exposing at least a portion of the inner core. .. An artificial heart valve device,
A fixing member having an annular fixing frame having an upstream portion and a downstream portion,
A tubular valve support having a first portion connected to the downstream portion of the anchoring member and a second portion radially inwardly spaced from the upstream portion of the anchoring member;
At least movable from a closed position connected to the valve support and blocking blood flow through the valve support, and an open position allowing blood flow through the valve support in the downstream direction. A valve assembly having one leaflet;
An expander member coupled to the stationary frame and extending radially outwardly therefrom, the expander member comprising a plurality of wires, at least a portion of the wires being surrounded by an outer material. (A) the inner core is a first material, (b) the outer material is a second material different from the first material, and has a thickness; ) The wire comprises a plurality of recesses extending through at least a portion of the thickness of the outer material, and (d) a radiopaque material in the recesses; and an expansion member. Valve device. 15. The device of claim 14, wherein the upstream portion of the stationary frame is radially deformable without substantially deforming the second portion of the tubular valve support. 15. The device of claim 14, wherein the expansion member further comprises a sealing member extending along at least a portion of its length, the wire being coupled to the sealing member. 15. The device of claim 14, wherein the wire is integral with the upstream portion of the stationary frame. 15. The device of claim 14, wherein the wire is mechanically isolated from the fixed frame. 15. The device of claim 14, wherein the first material is radiopaque and the second material is a superelastic alloy. 15. The device of claim 14, wherein the therapeutic agent comprises at least one of an anti-inflammatory drug and a bioactive agent. The first material is radiopaque,
The second material is a superelastic alloy,
15. The device of claim 14, wherein the therapeutic agent comprises at least one of an anti-inflammatory drug and a bioactive agent. 15. The device of claim 14, wherein at least some of the plurality of recesses extend through the entire thickness of the outer material, thereby exposing at least a portion of the inner core. At least some of the plurality of recesses extend through the overall thickness of the outer material and at least a portion of the thickness of the inner core, such that at least some of the plurality of recesses include: 15. The device of claim 14, terminating at an intermediate depth within the inner core. 15. The device of claim 14, wherein the expansion member further comprises an intermediate material positioned between the inner core and the outer material. 25. The device of claim 24, wherein at least some of the recesses extend through the entire thickness of the outer material, thereby exposing at least a portion of the intermediate material. 25. The device of claim 24, wherein at least some of the recesses extend through a total thickness of the outer material and a total thickness of the intermediate material, thereby exposing at least a portion of the inner core. .. An artificial heart valve device,
An anchoring member having a radially expandable frame with an interior and an upstream portion and a downstream portion, the upstream portion being located at and/or downstream of a natural annulus of a heart valve of interest. An anchoring member comprising a tissue anchoring portion configured to be pressed outwardly against tissue and configured to be at least partially deformable to conform to the shape of said tissue;
A closed position that is positioned with respect to the fixing member and that blocks blood flow through the interior, and an open position that allows blood flow through the interior in the direction of flow from the upstream portion to the downstream portion. A valve having at least one leaflet movable from the valve, the valve remaining capable when the tissue anchoring portion is deformed to conform to the shape of the tissue. A valve inwardly spaced from the tissue fixation portion of the fixation member;
A expansion assembly extending laterally away from the upstream portion of the securing member in a deployed configuration, the expansion member being spaced apart from the first end of the securing member and the securing member. A plurality of individual fabric segments having an end of, the fabric segments being arranged side by side around the expansion member, and adjacent fabric segments being loosely coupled together by a flexible coupling means. A dilatation assembly whereby the second ends of adjacent fabric segments may be configured independently of each other in the deployed state. 28. The prosthetic heart valve device of claim 27, wherein the segment does not include a structural member. 28. The prosthetic heart valve device of claim 27, wherein the expansion member is configured to deform with respect to the expandable frame in the deployed configuration. 28. A prosthetic heart valve device according to claim 27, wherein the connecting means is elastic. 28. The prosthetic heart valve device of claim 27, wherein the connecting means is a suture. 28. The prosthetic heart valve device of claim 27, wherein the distal end of the segment coincides with the second end of the expansion member. 28. The prosthetic heart valve device of claim 27, wherein the segment is spaced from the expandable frame such that the segment is only indirectly connected to the anchoring member. The prosthetic heart valve device of claim 27, wherein the segment is directly connected to the expandable frame.

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